FDA Inspection
AMISUB (SFH), Inc. d/b/a Saint Francis Hospital IRB #1AMISUB (SFH), Inc. d/b/a Saint Francis Hospital IRB #1 – FDA Inspection, Sep 20, 2012
Record Details
This FDA Inspection record concerns AMISUB (SFH), Inc. d/b/a Saint Francis Hospital IRB #1, with an inspection on September 20, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 20, 2012
- Product Type
- Drugs
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ID · bebcca5e-66d3-4880-ab93-8e0604fd7ae7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 802490
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.109(f)Continuing review
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